CircumcisionNCT01877408
A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision
A study testing Open surgical circumcision and Unicirc device with tissue adhesive in people with Circumcision, run by Simunye Primary Health Care at 1 site in South Africa.
Trial summary
To identify a minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Circumcision
- What is being tested?
- Open surgical circumcision and Unicirc device with tissue adhesive
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2013to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men at least 18 years of age requesting circumcision
- No anatomical penile abnormalities or infections
- Able to provide informed consent to participate
- Willing to participate in follow-up visits
Who cannot join
- Current illness
- Penile abnormality or infection which contraindicates or would complicate circumcision
- History of bleeding disorder
- Past reaction to local anesthetic
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Simunye Primary Healthcare
Mitchells Plain, Western Cape
About this study
To identify a minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.
Read the detailed description
Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.
According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."
This randomized controlled trial compares the open surgical technique to an alternative minimally-invasive technique using a disposable Unicirc device with tissue adhesive. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.
The study will randomly assign participants to one of two groups:
- Unicirc device with tissue adhesive: 100 men
- Open surgical circumcision: 50 men
The participants will be evaluated during follow-up visits at 2 days, 7 days, 14 days, and 28 days after surgery.
- Conditions
- Circumcision
- Being tested
- Open surgical circumcision, Unicirc device with tissue adhesive
- Keywords
- disposable circumcision device, Tissue adhesive, Open surgical circumcision, Minimally-invasive circumcision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgical circumcisionProcedure or surgery
Open surgical circumcision using a technique approved by the WHO (dorsal slit)
Unicirc device with tissue adhesiveDevice
Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Open surgical circumcision | Active comparator | The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common. Receives: Procedure: Open surgical circumcision |
| Unicirc device with tissue adhesive | Experimental | Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training. Receives: Device: Unicirc device with tissue adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Duration
Amount of time from first manipulation of tissue under local anesthesia to dressing
Measured: 1 hour
Secondary outcomes (5)
Difficulty in Learning and Performing Technique
Evaluated by doctor survey based on 5 point Likert scale
- Unicirc is much easier
- Unicirc is easier
- Neutral
- Open surgical is easier
- Open surgical is much easier
Measured: 1 year
Number of Participants With Complete Wound Healing by Post-Surgery Week 4
Measured: Within 4 weeks after surgery
Pain Experienced
Pain experienced during and after the procedure evaluated using a 10 point pain scale (0 signifies no pain and 10 signifies maximal pain
Measured: Within 2 days after surgery
Overall Patient Satisfaction
Patient satisfaction evaluated with questionnaire using satisfaction scale
- Very satisfied
- Satisfied
- Not satisfied
Measured: Within 6 weeks after surgery
Cosmetic Result
Cosmetic result evaluated by classification of scar line as regular (straight without any irregularity), irregular (not completely straight), or scalloped (with a wavy appearance)
Measured: Within 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CircumcisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simunye Primary Health Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Millard, Simunye Primary Health Care
- Investigators
- Peter S Millard, MD, PhD, Principal investigator, Simunye Primary Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877408
- Sponsor's protocol ID
- UNICIRC SA
- Status last verified
- Sep 2018
- First submitted
- 11 Jun 2013
- Last updated
- 2 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision
- ClinicalTrials.gov ID
- NCT01877408
- Acronym / sponsor ID
- UNICIRC SA
- Conditions
- Circumcision
- Keywords
- disposable circumcision device, Tissue adhesive, Open surgical circumcision, Minimally-invasive circumcision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Simunye Primary Health CareUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Posted 6 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify a minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.
Detailed description
Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.
According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."
This randomized controlled trial compares the open surgical technique to an alternative minimally-invasive technique using a disposable Unicirc device with tissue adhesive. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.
The study will randomly assign participants to one of two groups:
- Unicirc device with tissue adhesive: 100 men
- Open surgical circumcision: 50 men
The participants will be evaluated during follow-up visits at 2 days, 7 days, 14 days, and 28 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open surgical circumcision | Active comparator | Procedure: Open surgical circumcisionThe open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common. |
| Unicirc device with tissue adhesive | Experimental | Device: Unicirc device with tissue adhesiveCoupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men at least 18 years of age requesting circumcision
- No anatomical penile abnormalities or infections
- Able to provide informed consent to participate
- Willing to participate in follow-up visits
Key exclusion criteria (4 listed)
- Current illness
- Penile abnormality or infection which contraindicates or would complicate circumcision
- History of bleeding disorder
- Past reaction to local anesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open surgical circumcisionOpen surgical circumcision using a technique approved by the WHO (dorsal slit) | Procedure or surgery | Open surgical circumcision |
| Unicirc device with tissue adhesiveRemoval of foreskin with Unicirc disposal device and wound sealing with tissue adhesive. | Device | Unicirc device with tissue adhesive |
Primary outcome
Intraoperative Duration
Time frame: 1 hour
Amount of time from first manipulation of tissue under local anesthesia to dressing
5 secondary outcomes
Difficulty in Learning and Performing Technique
Time frame: 1 year
Number of Participants With Complete Wound Healing by Post-Surgery Week 4
Time frame: Within 4 weeks after surgery
Pain Experienced
Time frame: Within 2 days after surgery
Overall Patient Satisfaction
Time frame: Within 6 weeks after surgery
Cosmetic Result
Time frame: Within 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter S Millard, MD, PhD principal investigator
Simunye Primary Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open surgical circumcision and Unicirc device with tissue adhesive in people with Circumcision, run by Simunye Primary Health Care at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Duration (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.